跳至主要内容
临床试验/NCT05358093
NCT05358093Unknown不适用

Retrospective Study of Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer

Assiut University0 个研究点目标入组 45 人开始时间: 2022年4月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
主要终点
retrospective study of cardiac toxicity in left breast cancer received hypofractionated radiotherapy

研究概览

简要总结

Worldwide, Breast cancer is the most common cancer in women,where 1.7 million new cases diagnosed in 2012 . In 2020 number doubled as 2.3 million women diagnosed with breast cancer. According to ACS 1 in 8 women in United states will develop breast cancer in her life .

Similarly again, In Egypt breast cancer is the most common malignancy in women about 22,700 new cases recorded in 2020. Accounting for 38.8% of cancers in this population and forecasted to be approximately 46,000 in 2050 .

Post-operative radiotherapy is fundamental part of treatment after either conservative surgery or mastectomy . Conventionally fractionated radiation therapy (CFRT) ,Delivering 45-50 GY in 1.8-2 GY daily fractions for 5 days per week over 5-7 weeks was the standard schedule to eradicate sub clinical disease ,sparing normal tissues .After the publication of long term results of randomized controlled trials (RCTs) comparing safety and effectiveness of hypo fractionated RT (HFRT)delivered in3 weeks ,vs. CFRT in node negative BC has been implemented . in 2008 numerous international guidelines recommended HFRT as the new standard being Cost effectiveness ,limited resources ,excessively long RT waiting lists ,Another important argument for HFRT utilization ,even assuming alpha/beta of 1.5GY ,is biologically milder or isoeffective for healthy tissues compered to CFRT .

Cardiac toxicity is potentially long or short term complication of various anticancer therapies systemic therapy as anthracyclines or biological agent implicated in causing irreversible cardiac dysfunction.

Radiotherapy also have cardio toxic effect through different mechanisms

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-75 years old
  • histopathology diagnosed
  • Left sided breast cancer
  • Receiving 3D hypofractionated radiotherapy
  • Patients should be non metastatic
  • performance status 0-2

排除标准

  • • Patient > 75 years old
  • Non histological diagnosed
  • Metastatic patient
  • Patient with cardiac or other co morbidity.
  • ECoG performance status >2
  • pregnant or lactating patients

结局指标

主要结局

retrospective study of cardiac toxicity in left breast cancer received hypofractionated radiotherapy

时间窗: baseline

detection of toxicity on cardiac ejection fraction in 45 patients received hypofractionated radiotherapy over left breast

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Hussien Ahmed Hussien

principle investigator

Assiut University

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